Signet Therapeutics Doses First Patient in Phase I Trial of Global First-in-Class Diffuse Gastric Cancer Drug SIGX1094

On December 26, 2024, Signet Therapeutics (hereinafter referred to as "Signet") announced that its self-developed global first targeted drug for diffuse gastric cancer, SIGX1094, successfully completed [the trial] at the Peking University Cancer Hospital.First Patient Dosed in Solid Tumor Trial（First Patient In，FPI）。

At the beginning of this month, the kick-off meeting for the Phase I clinical trial of the SIGX1094 project was held at the Peking University Cancer Hospital. Professor Shen Lin and Professor Gong Jifang from the Peking University Cancer Hospital, along with their team members, Dr. Zhang Haisheng, founder and CEO of Signet Therapeutics, and other core members, as well as representatives from the CRO, attended the meeting. The kick-off meeting featured an in-depth discussion on the clinical research protocol of SIGX1094 for the treatment of patients with diffuse gastric cancer and other advanced solid tumors. SIGX1094 has demonstrated significant therapeutic potential in preclinical models of diffuse gastric cancer and advanced ascites, while also showing excellent efficacy in preclinical studies involving metastatic ovarian cancer, triple-negative breast cancer, and pancreatic cancer.

Professor Shen Lin, a Beijing-based scholar, is an expert with outstanding contributions recognized by the city of Beijing and serves as the Chief Scientist of the National Key R&D Program's Chronic Disease Special Project. She is currently the Director of the Department of Gastrointestinal Medical Oncology and the Director of the Phase I Clinical Trial Ward at Peking University Cancer Hospital. Previously, she served as the Vice President of Peking University Cancer Hospital and the Deputy Director of the Beijing Cancer Prevention and Treatment Research Institute. In academia, Professor Shen holds several key positions: Chair of the Gastric Cancer Expert Committee of the Chinese Society of Clinical Oncology (CSCO), Chair of the Clinical Research Expert Committee of CSCO, Chair of the Precision Oncology Professional Committee of the Chinese Anti-Cancer Association (CACA), Inaugural Chair of the Tumor Drug Clinical Research Professional Committee of CACA, Vice Chair of the Colorectal Cancer Professional Committee of CACA, and Chair of the Clinical Oncology Professional Committee of the Chinese Medical Women's Association.

Professor Shen Lin has long been dedicated to precision treatment and translational research for gastrointestinal tumors, as well as clinical research on new anti-tumor drugs.Led multiple international and domestic clinical studies, facilitated the approval of 16 new drug indications, and changed more than 30 clinical practice guidelines both domestically and internationally.

Signet Therapeutics is the first biotech company in China to develop innovative targeted cancer drugs based on organoid disease models and AI. It was initially founded on the Harvard University campus and established its presence in Shenzhen by the end of 2020, securing nearly 220 million yuan in funding and project grants. The company currently has four drug pipelines, with the lead pipeline developing SIGX1094, the world’s first targeted drug for diffuse gastric cancer. It has obtained IND approval from both the U.S. FDA and China NMPA, and received Orphan Drug Designation from the U.S. FDA. The drug has now entered Phase I clinical trials.

Signet is not only the phonetic translation of "Signet" but also adheres to the vision of "full of hope, investigating things to acquire knowledge." The company leverages the critical role of organoid disease models that closely resemble patients' genomic characteristics in drug efficacy evaluation and novel target discovery. Combining AI-driven screening, synthesis, and optimization of small molecule compounds, Signet develops first-in-class innovative targeted drugs. The company has a 1200㎡ R&D facility and a 500㎡ experimental animal housing area. SIGNET's organoid platform not only serves its own drug pipeline but also actively empowers large pharmaceutical companies in new drug development. Collaborative partners include the University of Hong Kong, the Hong Kong University of Science and Technology, Shenzhen BioRay Pharma, and Genuine Biotech, contributing to the birth of more innovative drugs.